BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 1914059 · Received December 1, 2010

    Report

    Report Number
    1627487-2010-03351
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-03352. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008 CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL APPROX TWO MONTHS PRIOR AND SINCE THE INCIDENCE, HE IS EXPERIENCING OVERSTIMULATION WHEN HIS SCS SYSTEM IS IN USE. AN X-RAY WAS TAKEN; HOWEVER, THE RESULTS HAVE NOT BEEN DISCLOSED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 113958

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention